Clinical Trials Using CDK/JAK2/FLT3 Inhibitor TG02 Citrate
Clinical trials are research studies that involve people. The clinical trials on this list are studying CDK/JAK2/FLT3 Inhibitor TG02 Citrate. All trials on the list are supported by NCI.
NCI’s basic information about clinical trials explains the types and phases of trials and how they are carried out. Clinical trials look at new ways to prevent, detect, or treat disease. You may want to think about taking part in a clinical trial. Talk to your doctor for help in deciding if one is right for you.
TG02 Plus Dose-Dense or Metronomic Temozolomide Followed by Randomized Phase II Trial of TG02 Plus Temozolomide Versus Temozolomide Alone in Adults With Recurrent Anaplastic Astrocytoma and Glioblastoma
Background: TG02 is an investigational drug that penetrates the blood-brain barrier and might treat brain tumors. Temozolomide (TMZ) is a drug used to treat brain tumors. Objective: To find out if TG02 is safe, and to find out if it in combination with TMZ is as effective as TMZ alone in people with brain tumors. Eligibility: People ages 18 and older with a brain tumor that has progressed after standard treatment Design: In phase I part, the Bayesian optimal interval (BOIN) design will be used to find the MTD of TG02 for Arm 1 (dose dense TMZ) and Arm 2 (metronomic TMZ) independently. In Phase II part, a Bayesian design based on posterior probability will be used to monitor eficacy. Participants will be screened with: Medical history Physical exam Blood and urine tests MRI of the brain if they have not had one in 14 days Heart test Tissue sample from prior surgeries Participants will take TG02 plus TMZ by mouth in 28-day cycles. Some will take TMZ for 7 days on and 7 days off. Others will take it every day. They will all take TG02 three days before Cycle 1, and then on four days during every cycle. They will all get treatment to prevent vomiting and diarrhea before and for 24 hours after each TG02 dose. They will all keep a diary of when they take the drugs and their symptoms. Participants will have study visits. These include: Physical exam, heart test, quality of life questionnaire, brain MRI, and urine tests every 4 weeks Blood tests every 2 weeks Participants will continue treatment until their disease gets worse or they have intolerable side effects. Participants will also be enrolled in another protocol to test molecular markers for their brain tumor.
Location: National Institutes of Health Clinical Center, Bethesda, Maryland